A Retrospective, Multinational, Multicentre, Observational Study in Patients Presenting With Native Severe Aortic Valve Stenosis and Treated With Myval™ Transcatheter Heart Valve Series in Real-world Setting.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Safety and Effectiveness as defined by the Valve Academic Research Consortium-3 (VARC-3)
研究概览
简要总结
A retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.
详细描述
Myval Global Study: A retrospective, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.
This study shall retrospectively collect the data of minimal 200 consecutive patients treated with Myval™ THV Series approximately 15 participating sites Globally.
Primary Endpoint:
Primary Combined Safety and Effectiveness Endpoint: [Time frame: 30 days]
It is the composite of following:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients of this study must have received Myval™ THV series for treatment of native severe aortic stenosis and completed a minimum of 30-day follow-up.
排除标准
- 未提供
结局指标
主要结局
Safety and Effectiveness as defined by the Valve Academic Research Consortium-3 (VARC-3)
时间窗: 30 day
It is the composite of following * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening or disabling bleeding * Acute kidney injury (stage 2 or 3) * Major vascular complications * Moderate or severe prosthetic valve regurgitation * Conduction system disturbances resulting in a new permanent pacemaker implantation
次要结局
- Major vascular complications(Pre-discharge, Through 30 days)
- All-cause mortality(30 day)
- Device Success(During hospital stay or maximum of 7 days after index procedure, whichever is earlier.)
- Endocarditis(Through 30 days)
- New permanent pacemaker implantation(Through 30 days)
- Moderate or severe prosthetic valve regurgitation(Through 30 days)
- Time related valve safety(Through 30 days)
- Echocardiographic End Points(Through 30 days])
- Major bleeding event(Through 30 days)
- All stroke(Through 30 days)
- Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4(Through 30 days)
- Bleeding type 3 and 4(Through 30 days)
- Functional improvement from baseline as measured(Baseline, 30 days)
- Conduction disturbances and arrhythmias(Through 30 days)
- Early safety at 30 days(After 30 days of index procedure)
- Clinical efficacy after 30 days(After 30 days of index procedure)
- Vascular and access related complications(Pre-discharge, Through 30 days)
- Pacemaker deployment (and the symptoms resulting in it)(Through 30 days)
- Patient-prosthesis Mismatch(Through 30 days)
- Length of index hospital stay(At discharge)
- Re-hospitalization(Through 30 days)
- New onset of atrial fibrillation or atrial flutter(Post-procedure, Pre-discharge and 30 days)
- Paravalvular Leak(Through 30 days)
- Degree of over - or Under-expansion of Myval(During Procedure)
- Interference with the mitral valve(During procedure)
- Myocardial rupture(During procedure)
- Accuracy of deployment in relation to the annular plane(During procedure)
- Interference with the LVOT(During procedure)